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Results of a Multice Prostate Cancer and Prostatic Diseases www.nature.com/pcan ARTICLE OPEN Clinical Research Comprehensive analysis of complications after transperineal prostate biopsy without antibiotic prophylaxis: results of a multicenter trial with 30 days’ follow-up ✉ Tobias Kohl1,6, August Sigle 2,6 , Timur Kuru3, Johannes Salem4, Hanjo Rolfs1, Tobias Kowalke1, Rodrigo Suarez-Ibarrola2, Jakob Michaelis2, Nadine Binder 5, Cordula A. Jilg2, Arkadiusz Miernik2, Markus T. Grabbert2, W. Schultze-Seemann2, Christian Gratzke2 and Daniel Porres1 © The Author(s) 2021 BACKGROUND: To investigate infectious and non-infectious complications after transperineal prostate biopsy (TPB) without antibiotic prophylaxis in a multicenter cohort. Secondly, to identify whether increasing the number of cores was predictive for the occurrence of complications. Thirdly, to examine the relation between TPB and erectile dysfunction. METHODS: We analyzed a retrospective multicenter cohort of 550 patients from three different urological centers undergoing TPB without antibiotic prophylaxis. The median number of cores was 26. Demographic and clinical data were extracted by reviewing patients’ electronic medical records and follow-up data such as postoperative complications obtained by structured phone interviews. To investigate the influence of the number of cores taken on the occurrence of complications, we performed univariate and multivariate mixed effects logistic regression models. RESULTS: There was no case of sepsis reported. Overall, 6.0% of patients (33/550) presented with any complication besides mild macrohematuria. In all, 46/47 (98%) complications were ≤Grade 2 according to Clavien–Dindo. In multivariate regression analyses, an increased number of cores was associated with overall complications (odds ratio (OR) 1.08, 95% confidence interval (CI) 1.02–1.14, P = 0.01) and specifically bleeding complications (OR 1.28, 95% CI 1.11–1.50, P = 0.01) but not with infectious complications (OR 1.03, 95% CI 0.97–1.10, P = 0.67). A total of 14.4% of patients referred impairment of erectile function after TPB. Of note, 98% of these men were diagnosed with prostate cancer. CONCLUSIONS: This is the first multicenter trial to investigate complications after TPB without antibiotic prophylaxis. In our study, we found no case of sepsis. This underlines the safety advantage of TPB even without antibiotic prophylaxis and supports the ongoing initiative to abandon TRB of the prostate. A higher number of cores were associated with an increase in overall complications specifically bleeding complications, but not with infectious complications. Post-biopsy erectile dysfunction was mainly present in patients diagnosed with PCa. Prostate Cancer and Prostatic Diseases; https://doi.org/10.1038/s41391-021-00423-3 INTRODUCTION TPB as a sterile procedure, restricting the use of antibiotics would be Until recently, transrectal biopsy (TRB) has been the real-world beneficial to address the global antibiotic resistance crisis and to standard for the histopathological diagnosis of prostate cancer (PCa) avoid medication side effects on an individual level [6, 7]. The [1]. Despite antibiotic prophylaxis, a dramatic rise in hospital primary aim of the study was to investigate the incidence of readmission rates of up to 10% and even in 30 days’ mortality has infectious and non-infectious complications after TPB without been reported in recent years [2, 3]. Fortunately, transperineal antibiotic prophylaxis in a multi-institutional setting. Second, we prostate biopsy (TPB) offers a promising solution to this current aimed for quantifying a potential association of number of cores challenge. In a recent meta-analysis including seven studies taken on the subsequent occurrence of complications. Moreover, we comparing TRB to TPB, the transperineal approach significantly analyzed whether there was any correlation between the number of decreased the risk of complications such as urogenital infections, cores taken and the occurrence of complications. The third objective rectal bleeding, and fever [4]. Moreover, TPB has shown an improved was to examine the relation between TPB and erectile diagnostic sensitivity for clinically significant PCa [5]. Considering dysfunction. 1Department of Urology, Klinikum Leverkusen, Leverkusen, Germany. 2Department of Urology, Faculty of Medicine, Medical Centre – University of Freiburg, Freiburg, Germany. 3Praxis am Ebertplatz, Cologne, Germany. 4Urology Department, Clinic LINKS VOM RHEIN, Cologne, Germany. 5Institute of Digitalization in Medicine, Faculty of Medicine, Medical ✉ Centre – University of Freiburg, Freiburg, Germany. 6These authors contributed equally: Tobias Kohl, August Sigle. email: [email protected] Received: 11 February 2021 Revised: 21 June 2021 Accepted: 28 June 2021 T. Kohl et al. 2 PATIENTS AND METHODS Table 1. Study population Baseline characteristics from 550 patients. We retrospectively obtained data from a multicenter cohort of 605 Parameter Value – Mean (+SD) consecutive patients who underwent TPB in one of the three participating medical centers. As this study was planned as a pilot study, the sample size Age (years) 68.3 (±8.1) was chosen with regard to the effort of data collection and acquisition Prostate volume (ccm) 58.3 (±30.4) periods were limited to 1 year. University Hospital Freiburg (UHF), Freiburg, PSA (ng/ml) 9.8 (±9.6) Germany, Municipal Hospital Leverkusen (MHL), Leverkusen, Germany, and one urological practice (UP) located in Cologne, Germany. Acquisition Number of cores 25.4 (±7.6) periods varied slightly between centers: UHF January 2019–December History of previous biopsy, n (%) 183 (33.3) 2019, MHL August 2019–July 2020, and UP March 2019–July 2020. The PI-RADS n/n (%) indication for TPB was based on elevated prostate-specific antigen (PSA), abnormal digital rectal examination, suspicious findings in multiparametric 2 15/550 (2.7) MRI (mpMRI), or as part of the re-biopsy routine under active surveillance. 3 84/550 (15.3) Fifty-five patients were excluded due to peri-interventional antibiotic therapy. Five hundred fifty men were included for final analyses. 4 266/550 (48.4) Institutional ethics approval was obtained (288/16). Due to the retro- 5 143/550 (26.0) spective nature and minimal risk of the study, written informed consent n/a 42/550 (7.6) was waived. This study was performed in accordance with the Declaration of Helsinki. Cancer detection rate n/n (%) Any cancer 357/550 (64.9) Biopsy procedure ISUP 1 98/550 (17.1) MpMRI–TRUS fusion prostate biopsy was performed using either a robotic- assisted approach with iSRobot Mona LisaTM® (Biobot Surgical, Singapore) ≥ISUP 2 259/550 (47.0) ® at UHF or using the BiopSee system (MedCom, Darmstadt, Germany) with ≥ISUP 3 115/550 (20.9) a template guided approach at MHL and at the urologic practice. fi Procedural details have been previously described in Refs [8] and [9], SD standard deviation, PSA prostate-speci c antigen, PI-RADS Prostate respectively. All centers applied a combined biopsy strategy by targeting Imaging: Reporting and Data System, ISUP International Society of suspicious lesions and performing a simultaneous systematic biopsy. Urological Pathology. Depending on target size, at least two cores were taken per target. 1234567890();,: Systematic biopsy was performed according to the Ginsburg scheme [10]. The number of systematic cores was dependent on prostate size. A median Table 2. Complications after transperineal biopsy in 550 patients. of 26 cores was taken per individual. The number of biopsy cores in the final analysis refers to the total number of cores (target cores plus Parameter Value – n/N (%) systematic cores). The procedure was performed in lithotomy position a under general anesthesia. Preoperative perineal preparation included an Any complication 33/550 (6.0) antiseptic wash with Octenidindihydrochloride/Phenoxyethanol or Complications according to Clavien–Dindo (CD) Povidon-Iod. Antibiotic prophylaxis was not administered. Alpha-blockers 1 20/550 (3.6) were not administered routinely as peri-interventional treatment. 2 26/550 (4.7) Data collection and statistical analysis 3a 1/550 (0.2) ’ Demographic and clinical data were extracted by reviewing patients Any infectious complicationb 20/550 (3.6) electronic medical records. Baseline characteristics included age, prostate volume by MRI, PSA, number of biopsy cores, history of previous biopsy, UTI with need of antibiotic therapy (CD 2) 19/550 (3.5) mpMRI findings according to the Prostate Imaging: Reporting and Data UTI with fever >38.5 °C (CD 2) 5/550 (0.9) System (PI-RADS) and histopathological prostate biopsy findings according to the classification of the International Society of Urological Pathology (ISUP). Prostatitis (CD 2) 2/550 (0.4) For follow-up, data such as postoperative complications from patients’ Urosepsis or ICU (CD 4) 0/550 (0) electronic medical records were validated and complemented by structured Death within 30 days (CD 5) 0/550 (0) phone interviews. Follow-up data included infectious complications such as c urinary tract infections (UTI), prostatitis and urosepsis, bleeding complica- Any relevant bleeding complication 8/550 (1.5) tions, acute urinary retention (AUR), and erectile dysfunction. UTI was defined Macrohematuria with irrigation (CD 1) 7/550 (1.3) as bacteriuria with concomitant clinical symptoms such as dysuria, urinary Bladder tamponade (CD 1) 2/550 (0.4) frequency, or suprapubic pain. Erectile function impairment was classified dichotomously as worsened or unchanged.
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